When treating patients with a new drug in combination with existing drugs, how do you separate the new drug's treatment effect? Management teams will point to historical data, but that is NOTORIOUSLY unreliable for either powering a pivotal trial or determining whether a new drug added to some existing drug has clinical efficacy.
The way you figure this out is to run randomized trials. When I say "no randomized experience" I mean no experience in a randomized trial to know for sure the magnitude of difference in efficacy, if any, between the existing drug and the new drug in combination with the existing drug.
Without randomized trials, management teams (and shareholders) are only guessing at the magnitude of benefit when powering their pivotal trial. This leads to underpowered trials that fail.
It has nothing to do with trusting management or the clinicians. It has to do with the right way and the wrong way to conduct a clinical program to maximize success.
David
Unless otherwise indicated, this is the personal viewpoint of David
Miller and not necessarily that of Biotech Stock Research, LLC.
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